Zalvos Adverse Reactions

Local IV reactions have been reported, followed in a few cases by phlebitis and thrombophlebitis.
Ciprofloxacin is generally well tolerated. During clinical research, 2,799 patients were treated with 2,868 series of the drug. Adverse reactions, eventually related to the drug appeared in 7.3% of the series, and non-related in 3.0%. Ciprofloxacin administration was interrupted in 3.5% because of adverse reactions. These concerned the gastrointestinal system (1.5%), the skin (0.6%) and CNS (0.4%). The reported events were: nausea (5.2%), diarrhea (2.3%), vomiting (2.0%), abdominal pain (1.7%), headache (1.2%), anxiety (1.1%), and anaphylactic reactions (1.1 %).
Additional events, without regard to drug relationship or route of administration, that occurred in 1% or less of Ciprofloxacin courses are listed as follows.
Gastrointestinal: Ileus; jaundice; gastrointestinal bleeding; C. difficile associated diarrhea; pseudomembranous colitis; pancreatitis; hepatic necrosis; intestinal perforation; dyspepsia; epigastric or abdominal pain; vomiting, constipation; oral ulceration; oral candidiasis; mouth dryness; anorexia; dysphagia; flatulence.
Central Nervous System: Convulsive seizures, paranoia, toxic psychosis, depression, dysphasia, phobia, depersonalization, manic reaction, unresponsiveness, ataxia, confusion, hallucinations, dizziness, lightheadedness, paresthesia, anxiety, tremor, insomnia, weakness, drowsiness, irritability, malaise, lethargy.
Skin/Hypersensitivity: Anaphylactic reactions; erythema multiforme/Stevens-Johnson syndrome; exfoliative dermatitis; toxic epidermal necrolysis; vasculitis; angioedema; edema of the lips face, neck, conjunctivae, hands or lower extremities; purpura; fever; chills; flushing; pruritus; urticaria; cutaneous candidiasis; vesicles; increased perspiration; hyperpigmentation; erythema nodosum; photosensitivity.
Allergic reactions ranging from urticaria to anaphylactic reactions have been reported.
Special Senses: Decreased visual acuity, blurred vision, disturbed vision (flashing lights, change in color perception, overbrightness of lights, diplopia), eye pain, anosmia, hearing loss, tinnitus, nystagmus, a bad taste.
Musculoskeletal: Joint pain, jaw, arm or back pain; joint stiffness neck and chest pain; achiness; flare up of gout.
Renal/Urogenital: Renal failure, interstitial nephritis, hemorrhagic cystitis, renal calculi, frequent urination, acidosis, urethral bleeding, polyuria, urinary retention, gynecomastia, candiduria, vaginitis. Crystalluria, cylinduria, hematuria and albuminuria have also been reported.
Cardiovascular: Cardiovascular collapse, cardiopulmonary arrest, myocardial infarction, arrhythmia, tachycardia, palpitation, cerebral thrombosis, syncope, cardiac murmur, hypertension, hypotension, angina pectoris.
Respiratory: Respiratory arrest, pulmonary embolism, dyspnea, pulmonary edema, respiratory distress, pleural effusion, hemoptysis, epistaxis, hiccup. Many of these events were described as only mild or moderate in severity, abated soon after the drug was discontinued and required no treatment. In several instances, nausea, vomiting, tremor, irritability or palpitation were judged by investigators to be related to elevated serum levels of Theophylline possibly as a result of drug interaction with Ciprofloxacin.